Multi-Criteria Decision Making for Medical Device Development

References

• Ahrens, M., & Hehenberger, P. (2015, July 27-30). Empathic-Design assisted by the Kano method - A human-centered design method for medical devices considering patients. In Proceedings of the International Conference on Engineering Design, ICED (Vol. 9, pp. 1–10). Bovisa Campus of Politecnico di.
   Google Scholar
• Aull-Hyde, R., Erdogan, S., & Duke, J.M. (2006). An experiment on the consistency of aggregated comparison matrices in AHP. European Journal of Operational Research, 171(1), 290–295. https://doi.org/10.1016/j.ejor.2004.06.037
   Web of Science ®Google Scholar
• Ben Rejeb, H., & Ben Younes, M.A. (2018). Proposition of a methodological framework for measuring innovation capacity of Tunisian companies. International Journal of Technology, Policy and Management, 18(2), 89–124. https://doi.org/10.1504/IJTPM.2018.092295
   Google Scholar
• Billard, R. (2014). Développement d’un implant à géométrie variable pour le traitement des fractures du fémur proximal chez les personnes âgées [ PhD Thesis]. University of Grenoble.
   Google Scholar
• Boje, D.M., & Murnighan, J.K. (1982). Group confidence pressures in iterative decisions. Management Science, 28(10), 1187–1196. https://doi.org/10.1287/mnsc.28.10.1187
   Web of Science ®Google Scholar
• Brook, J.W., & Pagnanelli, F. (2014). Integrating sustainability into innovation project portfolio management - A strategic perspective. Journal of Engineering and Technology Management - JET-M, 34(October 2014), 46–62. https://doi.org/10.1016/j.jengtecman.2013.11.004
   Google Scholar
• Brunelli, M. (2018). A survey of inconsistency indices for pairwise comparisons. International Journal of General Systems, 47(8), 751–771. https://doi.org/10.1080/03081079.2018.1523156
   Web of Science ®Google Scholar
• Burleson, W., Clark, S.S., Ransford, B., & Fu, K. (2012, June 3-7). Design challenges for secure implantable medical devices. In Proceedings - 49th Annual Design Automation Conference, DAC ’12 (pp. 12–17). https://doi.org/10.1145/2228360.2228364
   Google Scholar
• Cahill, R., Grimes, S.M., & Wilson, D.C. (2011). Review article: Extended producer responsibility for packaging wastes and WEEE - a comparison of implementation and the role of local authorities across Europe. Waste Management & Research, 29(5), 455–479. https://doi.org/10.1177/0734242X10379455
   PubMed Web of Science ®Google Scholar
• Carter, S.-S.-D., Costa, P.F., Vaquette, C., Ivanovski, S., Hutmacher, D.W., & Malda, J. (2017). Additive biomanufacturing: An advanced approach for periodontal tissue regeneration. Annals of Biomedical Engineering, 45(1), 12–22. https://doi.org/10.1007/s10439-016-1687-2
   PubMed Web of Science ®Google Scholar
• Chang, P.-T. (2005). Fuzzy strategic replacement analysis. European Journal of Operational Research, 160(2), 532–559. https://doi.org/10.1016/j.ejor.2003.07.001
   Web of Science ®Google Scholar
• Chaturvedi, J., Logan, A., Narayan, G., & Kuttappa, S. (2015). A structured process for unmet clinical need analysis for medical device innovation in India: Early experiences. BMJ Innovations, 1(3), 81–87. https://doi.org/10.1136/bmjinnov-2014-000010
   Google Scholar
• Cho, K.-T., & Kim, S.-M. (2003). Selecting medical devices and materials for development in Korea: The analytic hierarchy process approach. The International Journal of Health Planning and Management, 18(2), 161–174. https://doi.org/10.1002/hpm.703
   PubMed Web of Science ®Google Scholar
• Christer, A. H., & Scarf, P. A. (1994). A robust replacement model with applications to medical equipment. Journal of the Operational Research Society, 45(3), 261–275. https://doi.org/10.1057/jors.1994.39
   Web of Science ®Google Scholar
• Cooper, R.G. (2001). Winning at new products : Accelerating the process from idea to launch (3rd ed.). Perseus Publisher.
   Google Scholar
• Cooper, R.G. (2008). Perspective: The stage-gate ® idea-to-launch process—Update, what’s new, and NexGen systems. Journal of Product Innovation Management, 25(3), 213–232. https://doi.org/10.1111/j.1540-5885.2008.00296.x
   Web of Science ®Google Scholar
• Cooper, R.G., Edgett, S.J., & Kleinschmidt, E.J. (2002). Optimizing the stage-gate process: What best-practice companies Do-I. Research Technology Management, 45(5), 21–27. https://doi.org/10.1080/08956308.2002.11671518
   Web of Science ®Google Scholar
• Correia, T., Carapinheiro, G., Carvalho, H., Silva, J.M., & Dussault, G. (2017). The effects of austerity measures on quality of healthcare services: A national survey of physicians in the public and private sectors in Portugal. Human Resources for Health, 15(1), 82. https://doi.org/10.1186/s12960-017-0256-6
   PubMedGoogle Scholar
• Del Moral, M.J., Chiclana, F., Tapia, J.M., & Herrera-Viedma, E. (2018). A comparative study on consensus measures in group decision making. International Journal of Intelligent Systems, 33(8), 1624–1638. https://doi.org/10.1002/int.21954
   Web of Science ®Google Scholar
• Dong, Y., Zhang, G., Hong, W.-C., & Xu, Y. (2010). Consensus models for AHP group decision making under row geometric mean prioritization method. Decision Support Systems, 49(3), 281–289. https://doi.org/10.1016/j.dss.2010.03.003
   Web of Science ®Google Scholar
• Eberhardt, A.W., Johnson, O.L., Kirkland, W.B., Dobbs, J.H., & Moradi, L.G. (2016). Team-Based development of medical devices: An engineering-business collaborative. Journal of Biomechanical Engineering, 138(7). https://doi.org/10.1115/1.4032805
   Google Scholar
• Farhana, M., & Bimenyimana, E. (2015). Design driven innovation as a differentiation strategy - in the context of automotive industry. Journal of Technology Management and Innovation, 10(2), 24–38. https://doi.org/10.4067/S0718-27242015000200003
   Google Scholar
• Fearis, P.J., & Craft, B. (2016). Sustaining the success of medical device innovation. Surgery (United States), 160(5), 1130–1134. https://doi.org/10.1016/j.surg.2016.06.053
   Google Scholar
• Fennigkoh, L. (1992). A medical equipment replacement model. Journal of Clinical Engineering, 17(1), 43–47. https://doi.org/10.1097/00004669-199201000-00019
   PubMedGoogle Scholar
• Fleur, F. (1997). Medical devices and European regulatory” | “Les dispositifs medicaux et la reglementation europeenne. Annales Pharmaceutiques Francaises, 55(2), 73–76.
   PubMedGoogle Scholar
• Floyd, M.K., Barker, K., Rocco, C.M., & Whitman, M.G. (2017). A multi-criteria decision analysis technique for stochastic task criticality in project management. Engineering Management Journal, 29(3), 165–178. https://doi.org/10.1080/10429247.2017.1340038
   Web of Science ®Google Scholar
• Forthomme, J.P., Costenoble, V., Soete, P., & Docquier, J. (1993). Treatment of trochanteric fractures of the femur using the gamma nail (apropos of a series of 92 cases) | Traitement des fractures trochantériennes du fémur par le clou gamma (à propos d’une série de 92 cas). Acta Orthopaedica Belgica, 59(1), 22–29.
   PubMedGoogle Scholar
• Fries, R.C. (2013). Reliable design of medical devices (3rd ed.). CRC Pr I Llc.
   Google Scholar
• Gerrish, P., Herrmann, E., Tyler, L., & Walsh, K. (2005). Challenges and constraints in designing implantable medical ICs. IEEE Transactions on Device and Materials Reliability, 5(3), 435–444. https://doi.org/10.1109/TDMR.2005.858914
   Web of Science ®Google Scholar
• Girling, A., Young, T., Brown, C., & Lilford, R. (2010). Early-Stage valuation of medical devices: The role of developmental uncertainty. Value in Health, 13(5), 585–591. https://doi.org/10.1111/j.1524-4733.2010.00726.x
   PubMed Web of Science ®Google Scholar
• Goepel, K.D.K. (2013, June 23-26). Implementing the analytic hierarchy process as a standard method for multi-criteria decision making in corporate enterprises-A new AHP excel template with multiple inputs. In Proceedings of the International Symposium on the Analytic Hierarchy Process. https://bpmsg.com/isahp_2013-13-03-13-goepel/
   Google Scholar
• Golden, B., Wasil, E., & Harker, P. (1989). The analytic hierarchy process: Applications and studies. Springer-Verlag.
   Google Scholar
• Gosavi, A., Cudney, E.A., Murray, S.L., & Masek, C.M. (2016). Analysis of clinic layouts and patient-centered procedural innovations using discrete-event simulation. Engineering Management Journal, 28(3), 134–144. https://doi.org/10.1080/10429247.2016.1195664
   Web of Science ®Google Scholar
• Griffin, A., & Page, A.L. (1996). PDMA success measurement project: Recommended measures for product development success and failure. Journal of Product Innovation Management, 13(6), 478–496. https://doi.org/10.1016/S0737-6782(96)00052-5
   Web of Science ®Google Scholar
• Harris, A. (2013). Bridging the valley of death. Engineering & Technology, 8(9), 78–81. https://doi.org/10.1049/et.2013.0910
   Google Scholar
• Hede, S., Nunes, M.J.L., Ferreira, P.F.V., & Rocha, L.A. (2013). Incorporating sustainability in decision-making for medical device development. Technology in Society, 35(4), 276–293. https://doi.org/10.1016/j.techsoc.2013.09.003
   Google Scholar
• Hisarciklilar, O., Rasoulifar, R., Boujut, J.-F., Thomann, G., & Villeneuve, F. (2009). User-Designer collaboration in the design process of surgical instruments: New aspects for annotation as a communication tool. In M.N. Bergendahl; M. Grimheden; L. Leifer; P. Skogstad, and U. Lindemann (Eds.), Proceedings of ICED 09, the 17th International Conference on Engineering Design, Vol. 8, Design Information and Knowledge Palo Alto, CA, (Vol. 8, pp. 171–182).
   Google Scholar
• Holland, W.W. (2017). Health improvement in a period of austerity: A public health perspective. Global Policy, 8, 30–37. https://doi.org/10.1111/1758-5899.12216
   Web of Science ®Google Scholar
• Ivlev, I., Vacek, J., & Kneppo, P. (2015). Multi-criteria decision analysis for supporting the selection of medical devices under uncertainty. European Journal of Operational Research, 247(1), 216–228. https://doi.org/10.1016/j.ejor.2015.05.075
   Web of Science ®Google Scholar
• Jayaram, J., & Narasimhan, R. (2007). The influence of new product development competitive capabilities on project performance. IEEE Transactions on Engineering Management, 54(2), 241–256. https://doi.org/10.1109/TEM.2007.893992
   Web of Science ®Google Scholar
• Kang, W., & Montoya, M. (2014). The impact of product portfolio strategy on financial performance: The roles of product development and market entry decisions. Journal of Product Innovation Management, 31(3), 516–534. https://doi.org/10.1111/jpim.12111
   Web of Science ®Google Scholar
• Karlsen, J.T. (2002). Project stakeholder management. Engineering Management Journal, 14(4), 19–24. https://doi.org/10.1080/10429247.2002.11415180
   Google Scholar
• Koen, P., Ajamian, G., Boyce, S., Clamen, A., Fischer, E., Fountoulakis, S. …, & Seibert, R. (2002). Fuzzy-Front end: Effective methods, tools and techniques. In P. Belliveau; A. Griffin, and S. Soremrmeyer (Eds.), PDMA toolbook 1 for new product development (pp. 2–35). John Willey & Sons.
   Google Scholar
• Kramer, D.B., Xu, S., & Kesselheim, A.S. (2012). Regulation of medical devices in the United States and European Union. The New England Journal of Medicine, 366(9), 848–855. https://doi.org/10.1056/NEJMhle1113918
   PubMed Web of Science ®Google Scholar
• Kumar, S., & Bisson, J. (2008). Utilizing analytic hierarchy process for improved decision making within supply chains. Human Systems Management, 27(1), 49–62. https://doi.org/10.3233/HSM-2008-27105
   Google Scholar
• Kumar, C.V.S., & Routroy, S. (2016). Case application of a methodology for determining a manufacturer’s preferred customer status with suppliers. Engineering Management Journal, 28(1), 25–38. https://doi.org/10.1080/10429247.2016.1139911
   Web of Science ®Google Scholar
• Kunsch, P.L., & Brans, J.-P. (2019). Visualising multi-criteria weight elicitation by multiple stakeholders in complex decision systems. Operational Research, 1–17. https://doi.org/10.1007/s12351-018-00446-0
   Google Scholar
• Maisel, W.H. (2004). Medical device regulation: An introduction for the practicing physician. Annals of Internal Medicine, 140(4), 296–302. https://doi.org/10.7326/0003-4819-140-4-200402170-00012
   PubMed Web of Science ®Google Scholar
• Markham, S.K. (2002). Moving technologies from lab to market. Research Technology Management, 45(6), 31–42. https://doi.org/10.1080/08956308.2002.11671531
   Web of Science ®Google Scholar
• Markiewicz, K., van Til, J.A., Steuten, L.M.G., & Ijzerman, M.J. (2016). Commercial viability of medical devices using headroom and return on investment calculation. Technological Forecasting and Social Change, 112, 338–346. https://doi.org/10.1016/j.techfore.2016.07.041
   Web of Science ®Google Scholar
• Mayers, K., Lifset, R., Bodenhoefer, K., & Van Wassenhove, L.N. (2013). Implementing individual producer responsibility for waste electrical and electronic equipment through improved financing. Journal of Industrial Ecology, 17(2), 186–198. https://doi.org/10.1111/j.1530-9290.2012.00528.x
   Web of Science ®Google Scholar
• Miller, G.A. (1956). The magical number seven, plus or minus two: Some limits on our capacity for processing information. Psychological Review, 63(2), 81–97. https://doi.org/10.1037/h0043158
   PubMed Web of Science ®Google Scholar
• Moultrie, J., Sutcliffe, L., & Maier, A. (2015). Exploratory study of the state of environmentally conscious design in the medical device industry. Journal of Cleaner Production, 108, 363–376. https://doi.org/10.1016/j.jclepro.2015.06.014
   Web of Science ®Google Scholar
• Mummolo, G., Ranieri, L., Bevilacqua, V., Galli, P., Menolascina, F., & Padovano, G. (2007). A fuzzy approach for medical equipment replacement planning. In Proceedings of the 3rd International Conference on Maintenance and Facility Management, Rome, Italy, 27-28, September, 229–235.
   Google Scholar
• Nemeth, C., Nunnally, M., Bitan, Y., Nunnally, S., & Cook, R.I. (2009). Between choice and chance: The role of human factors in acute care equipment decisions. Journal of Patient Safety, 5(2), 114–121. https://doi.org/10.1097/PTS.0b013e3181a974d9
   PubMedGoogle Scholar
• Niederländer, C., Wahlster, P., Kriza, C., & Kolominsky-Rabas, P. (2013). Registries of implantable medical devices in Europe. Health Policy, 113(1–2), 20–37. https://doi.org/10.1016/j.healthpol.2013.08.008
   PubMed Web of Science ®Google Scholar
• NIST. (2017). Medical device reliability. National Institute of Standards and Technology. Retrieved July 4, 2017, from http://www.nist.gov/mml/acmd/biological_environments/medical-device-reliability2.cfm
   Google Scholar
• Ouda, B. K., Mohamed, A. S. A., & Saleh, N. S. K. (2010). A simple quantitative model for replacement of medical equipment proposed to developing countries. 5th Cairo International Biomedical Engineering Conference, 188–191. doi:10.1109/CIBEC.2010.5716050
   Google Scholar
• Park, W., Lee, K., Doo, S., & Yoon, S.-S. (2016). Investments for new product development: A break-even time analysis. Engineering Management Journal, 28(3), 158–167. https://doi.org/10.1080/10429247.2016.1199747
   Web of Science ®Google Scholar
• Parthasarthy, R., & Hammond, J. (2002). Product innovation input and outcome: Moderating effects of the innovation process. Journal of Engineering and Technology Management - JET-M, 19(1), 75–91. https://doi.org/10.1016/S0923-4748(01)00047-9
   Google Scholar
• Pauwels, K., Huys, I., Casteels, M., & Simoens, S. (2014). Drug shortages in European countries: A trade-off between market attractiveness and cost containment? BMC Health Services Research, 14(1). https://doi.org/10.1186/1472-6963-14-438
   Google Scholar
• Persaud, A. (2005). Enhancing synergistic innovative capability in multinational corporations: An empirical investigation. Journal of Product Innovation Management, 22(5), 412–429. https://doi.org/10.1111/j.1540-5885.2005.00138.x
   Web of Science ®Google Scholar
• Pietzsch, J.B., Shluzas, L.A., Pateé-Cornell, M.E., Yock, P.G., & Linehan, J.H. (2009). Stage-Gate process for the development of medical devices. Journal of Medical Devices, 3(2), 021004. https://doi.org/10.1115/1.3148836
   Google Scholar
• Piuzzi, N.S., Ng, M., Song, S., Bigach, S., Khlopas, A., Salas-Vega, S., & Mont, M.A. (2019). Consolidation and maturation of the orthopaedic medical device market between 1999 and 2015. European Journal of Orthopaedic Surgery & Traumatology, 29(4), 759–766. https://doi.org/10.1007/s00590-019-02372-z
   PubMedGoogle Scholar
• Ray, T.G., & Triantaphyllou, E. (1998). Evaluation of rankings with regard to the possible number of agreements and conflicts. European Journal of Operational Research, 106(1), 129–136. https://doi.org/10.1016/S0377-2217(97)00304-4
   Web of Science ®Google Scholar
• Rogers, W.A., Mykityshyn, A.L., Campbell, R.H., & Fisk, A.D. (2001). Analysis of a “simple” medical device. Ergonomics in Design, 9(1), 585–591. https://doi.org/10.1177/106480460100900103
   Google Scholar
• Rotter, V.S., Chancerel, P., & Schill, W.-P. (2011). Practicalities of individual producer responsibility under the WEEE directive: Experiences in Germany. Waste Management & Research, 29(9), 931–944. https://doi.org/10.1177/0734242X11415753
   PubMed Web of Science ®Google Scholar
• Russell, R.K., & Tippett, D.D. (2008). Critical success factors for the fuzzy front end of innovation in the medical device industry. EMJ - Engineering Management Journal, 20(3), 36–43. https://doi.org/10.1080/10429247.2008.11431775
   Web of Science ®Google Scholar
• Saaty, T.L. (1980). The analysis hierarchy process. McGraw-Hill.
   Google Scholar
• Salgado, E.G., Sanches da Silva, C.E., Mello, C.H.P., & Samaan, M. (2017). Critical success factors for new product development in biotechnology companies. Engineering Management Journal, 29(3), 140–153. https://doi.org/10.1080/10429247.2017.1344504
   Web of Science ®Google Scholar
• Santos, I.C.T. (2013). Product development methodologies: The case of medical devices [ Phd Thesis]. Faculdade de Engenharia da Universidade do Porto,
   Google Scholar
• Santos, I.C.T., Gazelle, G.S., Rocha, L.A., & Tavares, J.M.R.S. (2012a). Medical device specificities: Opportunities for a dedicated product development methodology. Expert Review of Medical Devices, 9(3), 299–311. https://doi.org/10.1586/erd.12.3
   PubMed Web of Science ®Google Scholar
• Santos I.C.T., Gazelle G.S., Rocha L.A., Tavares J.M.R.S. (2012b). An ontology model for the medical device development process in Europe. 1st International Conference on Design and PROcesses for MEdical Devices - PROMED 2012, University of Brescia Padenghe sul Garda, Brescia, Italy, Mai 2-4, 179–186.
   Google Scholar
• Schultz, C., Globocnik, D., Kock, A., & Salomo, S. (2018). Application and performance impact of stage-gate systems - the role services in the firm’s business focus. R&D Management. (in press). https://doi.org/10.1111/radm.12341.
   Google Scholar
• Seamon, E. (2004). Achieving growth through an innovative culture. In P. Belliveau; A. Griffin, and S. Soremrmeyer (Eds.), PDMA toolbook 2 for new product development (pp. 3–32). John Willey & Sons.
   Google Scholar
• Taghipour, S., Banjevic, D., & Jardine, A.K.S. (2011). Prioritization of medical equipment for maintenance decisions. Journal of the Operational Research Society, 62(9), 1666–1687. https://doi.org/10.1057/jors.2010.106
   Web of Science ®Google Scholar
• Taylor, K., & Jackson, S. (2005). A medical equipment replacement score system. Journal of Clinical Engineering, 30(1), 37–41. https://doi.org/10.1097/00004669-200501000-00046
   Google Scholar
• Thompson, B.S., & Friess, D.A. (2019). Stakeholder preferences for payments for ecosystem services (PES) versus other environmental management approaches for mangrove forests. Journal of Environmental Management, 233, 636–648. https://doi.org/10.1016/J.JENVMAN.2018.12.032
   PubMed Web of Science ®Google Scholar
• Thrane, S., Blaabjerg, S., & Møller, R.H. (2010). Innovative path dependence: Making sense of product and service innovation in path dependent innovation processes. Research Policy, 39(7), 37–41. https://doi.org/10.1016/j.respol.2010.04.003
   Web of Science ®Google Scholar
• Tidd, J.J., & Bessant, J.R. (2013). Managing innovation: Integrating technological, market and organizational change (5th ed.). Wiley.
   Google Scholar
• Triantaphyllou, E., & Mann, S.H. (1989). An examination of the effectiveness of multi-dimensional decision-making methods: A decision-making paradox. Decision Support Systems, 5(3), 303–312. https://doi.org/10.1016/0167-9236(89)90037-7
   Google Scholar
• Wadstein, T. (1943). Osteosynthesis with screws in medial fractures op the neck of the femur. Acta Orthopaedica Scandinavica, 14(1–4), 251–269. https://doi.org/10.3109/17453674308988833
   Google Scholar
• Wessner, C.W. (2005). Driving innovations across the valley of death. Research Technology Management, 48(1), 9–12. https://doi.org/10.1080/08956308.2005.11657289
   Web of Science ®Google Scholar
• Yip, M.H., Phaal, R., & Probert, D.R. (2014). Stakeholder engagement in early stage product-service system development for healthcare informatics. Engineering Management Journal, 26(3), 52–62. https://doi.org/10.1080/10429247.2014.11432020
   Web of Science ®Google Scholar
• Zeping, W., Wang, W., Wang, D., Zhao, K., & Zhang, W. (2019). Global sensitivity analysis using orthogonal augmented radial basis function. Reliability Engineering & System Safety, 185, 291–302. https://doi.org/10.1016/J.RESS.2018.12.028
   Web of Science ®Google Scholar
• Zhibin, W., Huang, S., & Xu, J. (2019). Multi-Stage optimization models for individual consistency and group consensus with preference relations. European Journal of Operational Research, 275(1), 182–194. https://doi.org/10.1016/J.EJOR.2018.11.014
   Web of Science ®Google Scholar
• Zhibin, W., & Xu, J. (2012). A consistency and consensus based decision support model for group decision making with multiplicative preference relations. Decision Support Systems, 52(3), 757–767. https://doi.org/10.1016/j.dss.2011.11.022
   Web of Science ®Google Scholar
• Zuckerman, D.M., Brown, P., & Nissen, S.E. (2011). Medical device recalls and the FDA approval process. Archives of Internal Medicine, 171(11), 1006–1011. https://doi.org/10.1001/archinternmed.2011.30
   PubMedGoogle Scholar